Our client, a medical device company in Cork are currently looking to recruit an AO Manufacturing Engineer for their site.
Job Description / Information
- Leads the innovation and development of assigned project elements with an emphasis on the Electropolishing and Laser Marking manufacturing processes, associated technology and procedures required for the manufacture of New Products.
- Conduct and document all necessary testing and validation prior to product transfers.
- Participation in multifunctional product development teams to ensure seamless handover of new products and/or processes to production.
- Uses concurrent engineering and rapid prototyping techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs.
- Ensure quality of process and product as defined in appropriate OS and Material specifications.
- Ensure GMPs and system safety.
- Participate in FMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.
- Support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
- Provide training for manufacturing team members.
- Interface with Materials Science, Design and Quality Assurance departments to provide customer with a quality product in a timely manner.
- Validation, Appraisal and support of coating suppliers, machining suppliers and raw material suppliers e.g. Forgings, titanium etc.
- Communicate and participate in system and process troubleshooting with support team members and with external agents.
- Lead and participate cross functional and cross divisional process improvement initiatives.
- Provide engineering support for New Product and new process introduction, ensuring that all activities are completed and documented in accordance with New product Development Process.
- Process validation for New products and processes; VP, IQ, OQ, PQ and associated documentation.
- Conduct Gauge R&R studies for New products and new processes.
- Application and development of statistical tools for use in driving continuous improvement projects.
- Complete capability studies for in process inspection and generate subsequent Inspection documentation.
- All other duties as assigned.
- Degree in Mechanical Engineering or equivalent is required.
- The individual must have a minimum of 2 years' experience in an engineering role preferably within a CNC environment.
- Business understanding of operations and there impacts essential.
- High level of PC Skills required.
- Flexibility essential.
- Strong communication skills with both Internal and external agents.
- Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
- The individual should enjoy working in an aggressive, dynamic and results motivated team environment.
- Experience in an FDA regulated or regulated industry beneficial.
- Experience in a six sigma and Lean Manufacturing environment with proven improvement results.
- Green or Black Belt 6 Sigma qualifications.
- Ability to effectively work cross-functionally with Product Dev., Quality, etc.
For further information on this AO Manufacturing Engineer role in Cork please contact Deirdre Finnerty on 091730022 / email@example.com
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